For value analysis committees and supply chain
FDA DE NOVO AUTHORIZED · DEN250033 · PRODUCT CODE SHR · RX ONLY
A surgeon at your hospital has asked for XplantR™. This page answers what committees ask most: is it authorized, what does it cost in context, how is it supplied, and where are the documents.
No capital, no service contract, no new coding. Billed as a consumable under existing CPT 34830–34832; facility payment by MS-DRG.
Inventory is available for ordering today.
1. Regulatory standing
FDA granted XplantR™ De Novo classification on April 17, 2026. De Novo is the pathway for novel devices with no legally marketed predicate; this decision created a new Class II device type, and XplantR is the predicate for it. Future devices of this type require a 510(k).
Device: XplantR Explant Tool · Hjärta Care, LLC, Wauwatosa, WI
FDA: De Novo DEN250033 · Class II · Product Code SHR · Rx only
Regulation: 21 CFR 870.4520, Device for open surgical explant of endovascular prostheses
Indication: open surgical conversion after EVAR, to aid in disengaging the stent graft from the aorta
Establishment registration: Hjärta Care 3017785723; contract manufacturer STS Technical Services 3010811747 (ISO 13485:2016)
UDI-DI (GTIN): KRB-1923W 00860014007415 · KRB-2629W 00860014007408 (AccessGUDID)
How it is supplied and supported
Sterility and materials
E-beam sterilized, SAL 10⁻⁶ (ISO 11137)
2-year shelf life; single use, 1 per box
BioMed White resin, ISO 10993 evaluated
Not made with natural rubber latex or DEHP
Supply and ordering
Ships from sterilized stock in 1–2 business days
Minimum order: 1 unit; Net 30
Volume bundle pricing across your health system
Not under any GPO contract; purchased direct
Quality and disclosure
QMS to ISO 13485:2016 and 21 CFR Part 820
No recalls to date; MDRs under 21 CFR Part 803
Free in-service before first use
Co-inventor Dr. Brown holds no financial interest in Hjärta Care
2. Cost in context and sizing
XplantR™ is used only in open explant cases. The question is not unit price alone, but what the explant step costs without it.
Net cost per case: at list price, OR time released and reprocessing avoided bring net acquisition cost to $3,965–$4,655.
One avoided complication ($50K–$75K) exceeds annual net device cost for a program doing up to 10–16 explants a year.
Coding: consumable under existing CPT 34830–34832; facility payment by MS-DRG. No capital expenditure.
Size by aortic inner diameter, not nominal graft diameter:
19–26 mm aortic ID → KRB-1923W (Small/Medium)
26–29+ mm aortic ID → KRB-2629W (Large/XL)
Pricing and volume terms are provided to your contracting or supply chain contact on request.
3. Review documents
XplantR brochure (LC0012 REV B) · Instructions for Use · FDA De Novo decision · AccessGUDID
Available to your committee on request: VAC Supplier Information Sheet (LC0017), W-9, certificate of insurance, sterilization and biocompatibility summaries, ISO 13485 certificate, Clinical Value Dossier (LC0013), Economic Model (LC0014), VAC Justification (LC0015) and Coding & Reimbursement Reference (LC0016).
Standard Explant Educational Video
Tissue Ingrowth Complicating Explant
Questions from your committee?
Send us your committee's questions, or ask for the full VAC packet. In-service is provided at no charge before first use.
Brian Thorson, Founder · (262) 219-9162 · brian@hjarta.care · Purchase orders: order@hjartacare.org
